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The clinical study of Apatinib mesylate combined with Temozolomide in treating patients with recurrent high-grade glioma

The clinical study of Apatinib mesylate combined with Temozolomide in treating patients with recurrent high-grade glioma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16010108
Enrollment
Unknown
Registered
2016-12-08
Start date
2016-11-25
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

Sponsors

the First affiliated Hospital of SooChow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 years and more; 2. patients with high-grade glioma (WHO III, IV) diagnosed by pathological; 3. Recurrent paitents treated with Stupp regimen ,Radiotherapy alone or chemoradiotherapy over 3 months after surgery; 4. Measurable lesions on cranial magnetic resonance; 5. ECOG score 0-2 6. Expected lifetime acuity = 3 months; 7. No serious function damageof heart, lung and bone marrow, no bleeding tendency, always no cerebral embolism and cerebral hemorrhage medical history No serious hypertension, etc., no serious postoperative complications (including intracranial hematoma and severe intracranial infection; 8. Subjects received treatment caused other damage has been restored, which accepts nitroso or mitomycin interval >=6 weeks; acceptance of other cytotoxic drugs, radiation or surgery >=4 weeks, and the wound has healed completely; 9. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: 1) HB=90 g/L (14 days without blood transfusion); 2) ANC=1.5×10^9/L; 3) PLT=80×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: 1) TBIL=1.5×ULN (higher than the normal limit); 2) ALT and AST=2.5×ULNif has liver metastasis ALT and AST=5×ULN; 3) Serum Cr=1×ULN the endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); 10. Women of childbearing age must be enrolled in the 7 days before a pregnancy test (serum or urine) results were negative, and the voluntary during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception; for men, surgical sterilization should be, or agreed during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception; 11. signed informed consent, compliance is good and agreed to cooperate with the survival of follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactation women; 2. suffering from hypertension, the antihypertensive drug therapy can not be reduced to the normal range (systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), with level-I myocardial ischemia or myocardial infarctionwith level-I arrhythmia (including QT interval=440 ms) or cardiac insufficiency; 3. The influence of oral drugs and absorption of a variety of factors (Such as unable to swallow, after resection of gastrointestinal tract, chronic diarrhea and intestinal obstruction); 4. Coagulant function abnormality, was treated with thrombolysis or anticoagulation, with a bleeding tendency or there are clear gastrointestinal bleeding concerns, (such as: there are local active ulcer lesions, defecate occult blood as positive); 5. A period of 4 weeks prior to the start of taking the study drug, =CTCAE 2 pneumorrhagia or =CTCAE 3 other organs bleeding event has occurred; 6. A period of 6 months prior to the start of the study dynamic/enous thromboembolism event has occurred, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc; 7. using anticoagulants or vitamin K antagonists such as warfarin, heparin or an analogue thereof; in prothrombin time international normalized ratio (INR) <=1.5 premise, to permit the use of low-dose warfarin (adult, 0.6~1.2 million U, once daily) or low-dose aspirin (=100 mg daily dose); 8. Investigator judgment that may affect the conduct of clinical studies and case studies determined.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactHuang Yulun

the First affiliated Hospital of SooChow University

huangyulun@suda.edu.cn+86 13013889432

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026